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Cuba: A Pharmaceutical Regulatory Snapshot

Executive Summary

Despite many restrictions, the nation is a potential market for imported drugs.

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Xpovio Avoided Complete Response Letter Through Late-Cycle Submission Of BOSTON Data

After US FDA's Oncologic Drugs Advisory Committee voted to delay approval of Karyopharm's multiple myeloma drug Xpovio, the company submitted some data from the Phase III BOSTON trial, which prompted the FDA to award an accelerated approval for a narrower indication.

Xpovio Clinical Development Timeline

Chronicle of the development and review of Karyopharm's Xpovio (selinexor) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies.

Xpovio's US FDA Review: A Primer On How (Not) To Submit Real-World Data

Karyopharm included a real-world data study to support its Xpovio NDA, but the US FDA deemed the study inadequate for an overall survival comparison to the pivotal STORM trial.

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